Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more "personalized" chemotherapy regimen.the hypothesis is that mFOLFIRINOX regimen could be a good candidate for challenging the platinum-etoposide regimen in patients with metastatic G3 NEC of GEP or unknown origin. Furthermore, in order to get insights in the putative predictive biomarkers of efficacy of these two regimens, an effort toward a precise molecular characterization of these tumors is required in order to be able to define which subgroup of G3 NEC needs to be treated by which chemotherapy regimen. The FOLFIRINEC trial is set up in order to try to answer these questions

Eligibility criteria

Qualifiers

Grade 3 neuroendocrine carcinoma or high grade MiNEN with a grade 3 poorly differentiated neuroendocrine carcinoma component ≥30% of gastro-entero-pancreatic or unknown primary

Poorly differentiated

Small cell or large cell or non-small cell or non- typeable

Metastatic disease

Disqualifiers

Grade 3 well differentiated neuroendocrine tumor according to WHO 2017 classification

Severe renal impairment (creatinine clearance less than 30 mL/min, MDRD)

Partial or complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)

Gilbert's syndrome

Trial design

Treatments tested in this trial

  • FOLFOXIRI Protocol
  • Cisplatin injection

Treatment groups

218 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire Dijon

Lead sponsor

National Cancer Institute, France

Collaborator